Key Learnings From Marissa’s Experience
- Make sure that you’re solving a real problem rather than creating solutions in search of a gap. Identify a genuine need and develop a product that enhances efficiency and outcomes while fitting seamlessly into existing workflows.
- When engaging with FDA, explain your technology in layman's terms. Leverage predicates if they’re available. Design trials primarily for regulatory purposes, but ensure they’re equitable for broader credibility.
- Accelerators are valuable for startups at any stage. They can offer networks, new perspectives, publicity, and even potential funding opportunities. However, they are also time-consuming, so assess the benefits and choose wisely.
Marissa Fayer is an engineer, medtech executive, entrepreneur, investor, philanthropist, and previously served in leadership roles at a series of medtech companies. Currently, she’s at the helm of DeepLook Medical, where her team is developing AI-powered software for medical imaging to aid radiologists with diagnoses.
Marissa’s 15-year career in healthcare has included roles in various functions, including product development, manufacturing, engineering, and business development. She joined DeepLook in 2020 as a member of the advisory board – which happened to be right before COVID – and became their CEO two years after, a journey she eloquently details in this Crunchbase article.
With its broad software applications, DeepLook is dedicated to providing versatile use-cases of its technology. Its flagship product, DL Precise, is a deterministic AI software that measures, segments, and visualizes lesions in existing images of mammograms, ultrasounds, CTs, and MRIs. Approved by FDA, DeepLook improves diagnostic accuracy, improves the radiologists’ and oncologists’ workflow, and assists clinicians in developing treatment plans.
DL Precise particularly excels in identifying both cancerous and non-cancerous lesions in dense tissue, especially breasts. Marissa’s personal connection to this work is strong. "As a woman who has dense breast tissue, this is deeply personal," Marissa shares. This condition affects 45% of women worldwide, disproportionately affecting Black, Asian, and Jewish women. The issue with dense breast tissue, or any dense tissue for that matter, is that it's 2-3 times more likely to develop cancer. Moreover, and perhaps more concerningly, it can make cancer harder to detect in imaging scans.
DeepLook’s commercial traction is accelerating, but its approach to the market is not through direct sales. Instead, DeepLook has partnered up with established players like Tempus, Barco, Radical Imaging, and Blackford. Marissa explains, “A small technology company is not going to make inroads into a hospital, but our partners have the ability to make those calls and to get in more efficiently. That's how we get into the radiologists’ hands.”
Marissa Fayer, CEO of DeepLook Medical, has over two decades of experience as a medtech executive, entrepreneur, investor, and philanthropist, spanning companies like Hologic and Olympus. She’s the founder of HERhealthEQ, a non-profit focused on advancing global women's health, and an entrepreneur-in-residence at Graybella Capital and Goddess Gaia Ventures. She’s a TEDx Speaker, a UCSC Miller Center Social Entrepreneur Fellow, and winner of the 2022 First in FemTech award.
Build Something Useful
Marissa joined DeepLook as an advisor in 2020 and became its CEO in 2022 when the company was past product development and on the precipice of commercialization. This wasn’t Marissa’s first rodeo; she’s been involved with a number of launches before.
When it comes to product development, Marissa emphasizes the importance of focusing on real, existing problems rather than conjuring up solutions for problems that don’t exist. “Don't just create something that has actually no value to anybody, and try to figure out how it fits,” she advises bluntly. You need to identify genuine needs and address them effectively. Ask physicians, hospital administrators, anybody actively involved in healthcare, “How can you make their day better?”
One critical aspect, especially in healthcare, is fitting into existing workflows. “Physicians, nurses, and anybody in healthcare has limited time. You have to either drastically change outcomes or reduce the amount of time spent on something,” Marissa observes. According to her, this approach – focusing on making their lives easier rather than overwhelming them with solutions that don’t fit into their daily practice – is absolutely essential.
Your goal should be to find a painful problem, understand it thoroughly, and then figure out how to integrate the solution into an existing workflow. Following this formula, Marissa’s approach is to start small and build iteratively. “You can't start at the endpoint,” she notes. “You have to start where people can understand it and where you can work.” In DeepLook’s case, they started with deterministic software without learning capabilities – thereby avoiding HIPAA complications. Gradually, over time, the team built the AI and ML algorithms into it.
Marissa’s overarching advice is to stay humble. Not every product needs to be a ‘unicorn’ – a rare, highly sought-after revolutionary piece of tech. Instead, she says, “99% of companies are not unicorns, but they're the ones that are propping up the economy. They're profitable and offer consistent returns to their investors. They're improving patients' lives and physicians' day-to-day workflow. Not everything is this pie-in-the-sky outcome.”
Start Simple and Explain It Clearly
Based on Marissa’s extensive cross-functional experience, she champions two key strategies when it comes to navigating the regulatory landscape: maintain simplicity and leverage existing predicate devices.
"The way we obtained regulatory clearance was by using very understandable code," she explains. The fact that they started with deterministic software, as opposed to AI – which is often less familiar to regulators – was an advantage in the beginning. In other words, start with simple concepts that non-experts can understand.
Marissa notes that the easiest regulatory path in most cases is a 510(k). “That was the route that we were lucky to have taken. That is the route we will probably continue to take.” If there’s a predicate in your domain, don’t miss the chance to capitalize on it. She also highlights the importance of demonstrating to regulators how your technology is “better, different, and how it can be utilized in the real world.”
Marissa also advises not to overcomplicate clinical studies. Design trials primarily for regulatory purposes at the start, and then you can run more complex studies later to demonstrate differentiation to end users. However, maintaining equitability is of utmost importance to her. Marissa illustrates, “You could be using a 20-year-old predicate. I guarantee you it’s not tested on women, people of color, etc.” Even if it's not required by FDA, testing your product on a diverse range of participants adds credibility to your clinical work.
Accelerators Are for Every Stage
Having participated in well-known accelerators like Massmedic Ignite and AARP Age-Tech Collective, Marissa is well-versed in their benefits and how to leverage them effectively.
She emphasizes that accelerators are not just for early-stage companies – they can also be pivotal for more mature startups. Being part of an accelerator helps you expand your network and brings different perspectives and viewpoints. As she calls out, “You don’t have to follow their process rigidly.” In Marissa’s case, the accelerators specifically gave her publicity and networking opportunities – which are essential if you’re about to go commercial – and opened up potential funding opportunities.
While the benefits are obvious, it’s important to pick the accelerator carefully. It has to align with your stage and needs. For instance, while Y Combinator might be ideal for early-stage tech startups, it may not offer much for companies approaching commercialization.
Seek Funds Outside of Your Niche
As an entrepreneur in residence (EIR) at Graybella Capital and Goddess Gaia Ventures, Marissa has a lot of experience on the other side of the table. Yet she quips, “Fundraising is the bane of my existence. I wish I never had to do it again.” The irony is, that she's both experienced and successful at it.
According to Marissa, it’s important to broaden your radar beyond your specific niche, while not straying too far either. For example, if your company is focused on women’s health, like DeepLook, you don’t have to limit your outreach to femtech investors. Marissa notes that only 2% of venture capital dollars go to women's health, even though females represent 51% of the population. This might apply to other industries too. “Building a diverse investor base gives you visibility, which is crucial, especially when planning an exit strategy,” Marissa explains.
During the actual fundraising process, you need to demonstrate well-thought-out plans and real progress. “Investors want to see tangible progress and potential, not just impressive presentations with no substantial work behind the surface,” Marissa shares. You need to set realistic expectations and stage-gated plans, and communicate both to potential investors.
Key Learnings From Marissa’s Experience
- Make sure that you’re solving a real problem rather than creating solutions in search of a gap. Identify a genuine need and develop a product that enhances efficiency and outcomes while fitting seamlessly into existing workflows.
- When engaging with FDA, explain your technology in layman's terms. Leverage predicates if they’re available. Design trials primarily for regulatory purposes, but ensure they’re equitable for broader credibility.
- Accelerators are valuable for startups at any stage. They can offer networks, new perspectives, publicity, and even potential funding opportunities. However, they are also time-consuming, so assess the benefits and choose wisely.
Marissa Fayer is an engineer, medtech executive, entrepreneur, investor, philanthropist, and previously served in leadership roles at a series of medtech companies. Currently, she’s at the helm of DeepLook Medical, where her team is developing AI-powered software for medical imaging to aid radiologists with diagnoses.
Marissa’s 15-year career in healthcare has included roles in various functions, including product development, manufacturing, engineering, and business development. She joined DeepLook in 2020 as a member of the advisory board – which happened to be right before COVID – and became their CEO two years after, a journey she eloquently details in this Crunchbase article.
With its broad software applications, DeepLook is dedicated to providing versatile use-cases of its technology. Its flagship product, DL Precise, is a deterministic AI software that measures, segments, and visualizes lesions in existing images of mammograms, ultrasounds, CTs, and MRIs. Approved by FDA, DeepLook improves diagnostic accuracy, improves the radiologists’ and oncologists’ workflow, and assists clinicians in developing treatment plans.
DL Precise particularly excels in identifying both cancerous and non-cancerous lesions in dense tissue, especially breasts. Marissa’s personal connection to this work is strong. "As a woman who has dense breast tissue, this is deeply personal," Marissa shares. This condition affects 45% of women worldwide, disproportionately affecting Black, Asian, and Jewish women. The issue with dense breast tissue, or any dense tissue for that matter, is that it's 2-3 times more likely to develop cancer. Moreover, and perhaps more concerningly, it can make cancer harder to detect in imaging scans.
DeepLook’s commercial traction is accelerating, but its approach to the market is not through direct sales. Instead, DeepLook has partnered up with established players like Tempus, Barco, Radical Imaging, and Blackford. Marissa explains, “A small technology company is not going to make inroads into a hospital, but our partners have the ability to make those calls and to get in more efficiently. That's how we get into the radiologists’ hands.”
Marissa Fayer, CEO of DeepLook Medical, has over two decades of experience as a medtech executive, entrepreneur, investor, and philanthropist, spanning companies like Hologic and Olympus. She’s the founder of HERhealthEQ, a non-profit focused on advancing global women's health, and an entrepreneur-in-residence at Graybella Capital and Goddess Gaia Ventures. She’s a TEDx Speaker, a UCSC Miller Center Social Entrepreneur Fellow, and winner of the 2022 First in FemTech award.
Build Something Useful
Marissa joined DeepLook as an advisor in 2020 and became its CEO in 2022 when the company was past product development and on the precipice of commercialization. This wasn’t Marissa’s first rodeo; she’s been involved with a number of launches before.
When it comes to product development, Marissa emphasizes the importance of focusing on real, existing problems rather than conjuring up solutions for problems that don’t exist. “Don't just create something that has actually no value to anybody, and try to figure out how it fits,” she advises bluntly. You need to identify genuine needs and address them effectively. Ask physicians, hospital administrators, anybody actively involved in healthcare, “How can you make their day better?”
One critical aspect, especially in healthcare, is fitting into existing workflows. “Physicians, nurses, and anybody in healthcare has limited time. You have to either drastically change outcomes or reduce the amount of time spent on something,” Marissa observes. According to her, this approach – focusing on making their lives easier rather than overwhelming them with solutions that don’t fit into their daily practice – is absolutely essential.
Your goal should be to find a painful problem, understand it thoroughly, and then figure out how to integrate the solution into an existing workflow. Following this formula, Marissa’s approach is to start small and build iteratively. “You can't start at the endpoint,” she notes. “You have to start where people can understand it and where you can work.” In DeepLook’s case, they started with deterministic software without learning capabilities – thereby avoiding HIPAA complications. Gradually, over time, the team built the AI and ML algorithms into it.
Marissa’s overarching advice is to stay humble. Not every product needs to be a ‘unicorn’ – a rare, highly sought-after revolutionary piece of tech. Instead, she says, “99% of companies are not unicorns, but they're the ones that are propping up the economy. They're profitable and offer consistent returns to their investors. They're improving patients' lives and physicians' day-to-day workflow. Not everything is this pie-in-the-sky outcome.”
Start Simple and Explain It Clearly
Based on Marissa’s extensive cross-functional experience, she champions two key strategies when it comes to navigating the regulatory landscape: maintain simplicity and leverage existing predicate devices.
"The way we obtained regulatory clearance was by using very understandable code," she explains. The fact that they started with deterministic software, as opposed to AI – which is often less familiar to regulators – was an advantage in the beginning. In other words, start with simple concepts that non-experts can understand.
Marissa notes that the easiest regulatory path in most cases is a 510(k). “That was the route that we were lucky to have taken. That is the route we will probably continue to take.” If there’s a predicate in your domain, don’t miss the chance to capitalize on it. She also highlights the importance of demonstrating to regulators how your technology is “better, different, and how it can be utilized in the real world.”
Marissa also advises not to overcomplicate clinical studies. Design trials primarily for regulatory purposes at the start, and then you can run more complex studies later to demonstrate differentiation to end users. However, maintaining equitability is of utmost importance to her. Marissa illustrates, “You could be using a 20-year-old predicate. I guarantee you it’s not tested on women, people of color, etc.” Even if it's not required by FDA, testing your product on a diverse range of participants adds credibility to your clinical work.
Accelerators Are for Every Stage
Having participated in well-known accelerators like Massmedic Ignite and AARP Age-Tech Collective, Marissa is well-versed in their benefits and how to leverage them effectively.
She emphasizes that accelerators are not just for early-stage companies – they can also be pivotal for more mature startups. Being part of an accelerator helps you expand your network and brings different perspectives and viewpoints. As she calls out, “You don’t have to follow their process rigidly.” In Marissa’s case, the accelerators specifically gave her publicity and networking opportunities – which are essential if you’re about to go commercial – and opened up potential funding opportunities.
While the benefits are obvious, it’s important to pick the accelerator carefully. It has to align with your stage and needs. For instance, while Y Combinator might be ideal for early-stage tech startups, it may not offer much for companies approaching commercialization.
Seek Funds Outside of Your Niche
As an entrepreneur in residence (EIR) at Graybella Capital and Goddess Gaia Ventures, Marissa has a lot of experience on the other side of the table. Yet she quips, “Fundraising is the bane of my existence. I wish I never had to do it again.” The irony is, that she's both experienced and successful at it.
According to Marissa, it’s important to broaden your radar beyond your specific niche, while not straying too far either. For example, if your company is focused on women’s health, like DeepLook, you don’t have to limit your outreach to femtech investors. Marissa notes that only 2% of venture capital dollars go to women's health, even though females represent 51% of the population. This might apply to other industries too. “Building a diverse investor base gives you visibility, which is crucial, especially when planning an exit strategy,” Marissa explains.
During the actual fundraising process, you need to demonstrate well-thought-out plans and real progress. “Investors want to see tangible progress and potential, not just impressive presentations with no substantial work behind the surface,” Marissa shares. You need to set realistic expectations and stage-gated plans, and communicate both to potential investors.
